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Directeur, Validation des systèmes informatiques (mondiaux) Director, Global Computerized Systems Validation - Canada  

Charles River (company)

Posted on : 28 August 2017

Project Description

For nearly 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

We are seeking an experienced Director of Global Computerized Systems Validation for our expanding business. This position can be based at any Charles River facility.

The role is responsible for the management and coordination of computerized systems test and validation efforts across all Charles River businesses.  Developing and directing computerized system validation processes compliant with all applicable global regulations (e.g., FDA and OECD GxPs, Sarbanes-Oxley, etc.). It will also develop and initiate the globalization of computer system validation across the organization from a validation resource and an operational perspective.  It also will manage the global operational team and pipeline of validation projects.

The following are minimum requirements related to the position:

  • Bachelor’s degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline
  • 5-7 years related experience in computer system validation. Prior experience working in a GxP laboratory is preferred.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Comprehensive knowledge of regulatory requirements, including GxPs, Part 11, and Sarbanes-Oxley as they pertain to computerized systems, is preferred. In-depth knowledge of current IT technologies and state-of-the-art practices, particularly in program management.  Strong interpersonal skills including influencing & aligning.  Effective communication skills for large, multinational audiences and the ability to express ideas clearly and effectively in written and oral form to all levels of the organization.
  • Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment.  Demonstrated ability to build consensus and affect change across departmental boundaries.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges.  Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015. 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~70% of the drugs approved by the FDA in 2016.

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Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer